Kornimate/medical-research-clean huggingface dataset:
e-sihle: an internet pregnancy prevention for older teenage girls

Conditions: Pregnancy; Sexually Transmitted Infections

Summary: the purpose of this study is to evaluate the efficacy of an online pregnancy prevention intervention that was adapted from the evidence based small group intervention sihle.

the investigators will test the hypothesis that by the end of the study, women who receive the e-sihle intervention will have a 35% increase in reliable contraception use compared to attention control website, divas, which is a health and nutrition education program. both arms of the study were designed for african-american women who are 18-19 years old.

Eligibility criteria:
inclusion criteria: * age 18 or 19 at enrollment * female * not currently pregnant or intending to become pregnant in the next 12 months * live in orleans or jefferson parish in louisiana * english is your primary language * access to a computer and internet connection * does not have sex with women exclusively exclusion criteria: * age younger than 18 or older than 19 * male * currently pregnant or intend to become pregnant in the next 12 months * live outside of orleans or jefferson parish * hearing impairments that prevent listening to videos

Keywords: pregnancy sti std
a phase 2 study to evaluate the efficacy and safety of amg531 in aplastic anemia

Conditions: Aplastic Anemia

Summary: the present study will be conducted to evaluate the efficacy and safety of amg531 and to determine the recommended initial dose of amg531 on the basis of its efficacy and safety when it is administered subcutaneously (sc) to the aplastic anemia (aa) patients with immunosuppressive-therapy refractory thrombocytopenia and also to assess the pharmacokinetics of this product. its efficacy and safety during the extension period beyond one year will also be evaluated.


Eligibility criteria:
inclusion criteria: * patient who is diagnosed as aa and refractory to immunosuppressive therapy * platelet ≤ 30,000/μl exclusion criteria: * concurrent active infection not adequately responding to appropriate therapy * hiv positivity * bone marrow reticulin grade of \> 1 * clinically significant cardiac disease * arterial or venous thrombosis within the last 1 year before enrollment * other cause of thrombocytopenia * aa with hemolytic predominant paroxysmal nocturnal hemoglobinuria (pnh) * uncontrolled diabetes * receiving any agent used to treat aa, including antithymocyte globulin (atg) or atg + cyclosporine within 6 months before starting study treatment and/or cyclosporine or anabolic hormone within 6 weeks before starting the study treatment * history of peg-rhumgdf, recombinant human thrombopoietin, amg531, and other thrombopoietin (tpo)-receptor agonist * who plans to conduct hematopoietic stem cell transplantation within 1 year

Keywords: anemia, aplastic thrombopoietin thrombocytopenia
phase i combination ixabepilone + cisplatin

Conditions: Non Small Cell Lung Cancer

Summary: the purpose of this study is to determine the highest dose of ixabepilone that can be given safely with cisplatin without causing severe or life-threatening side effects and for some patients with non-small cell lung cancer, the effects (good or bad) on your cancer will also be studied


Eligibility criteria:
escalation phase subjects: primary solid tumor not curable by local measures such as surgery, radiation inclusion criteria: * men and women age ≥ 18 exclusion: * more than 2 prior chemotherapy containing regimens for metastatic disease * no prior exposure to cisplatin or ixabepilone expansion phase subjects: advanced non-small cell lung cancer inclusion criteria: * men and women age ≥ 18 exclusion: * no prior chemotherapy-containing regimen for metastatic disease * no prior exposure to cisplatin or ixabepilone

Keywords: lung cancer (nsclc)
the use of virtual reality goggles

Conditions: Dental Anxiety

Summary: the purpose of this research study is to evaluate the effectiveness of virtual-reality audio-visual distraction goggles on pain and behavior scores in a population of 8-12 year old dental patients receiving routine dental care in an outpatient clinical setting.

all appointments will take place at the college of dentistry department of pediatric dentistry. the first day's appointment will consist of clinically-indicated cleaning, radiographs and treatment planning. toward the end of the first appointment, the participant will wear the virtual reality goggles for 5 minutes, in order to become familiar with the device. during these 5 minutes, fluoride varnish will be applied. the application of the varnish would occur whether the participant is in the research or not. at the second or third appointments, the goggles will be randomly used during the restorative treatment. whether the participant uses the goggles at the second or third visit will be determined purely by chance, like flipping a coin. no nitrous oxide will be used, but local anesthesia will still be administered as standard. the participant will use a 1-10 scale at the end of each appointment to rate pain levels, and a research team member(the dental assistant) will assign a 1-4 scale value for behavior. the 1-10 scale will consist of the wong-baker faces pain scale.

Eligibility criteria:
inclusion criteria: * healthy, no history of seizures or neurological disturbance, requires two quadrants of dentistry exclusion criteria: * history of dental anxiety
safety and immunogenicity of 3 lots of gsk biologicals' hbv-mpl vaccine and engerix™-b in healthy volunteers ≥ 15y

Conditions: Hepatitis B

Summary: this study was conducted to evaluate the lot-to-lot consistency of three lots of hbv-mpl vaccine and to compare their safety and immunogenicity with that of engerix™-b.

at the time of conduct of this study, the sponsor glaxosmithkline was known by its former name smithkline beecham

Eligibility criteria:
inclusion criteria: * a male or female aged ≥ 15 years at the time of the first vaccination. in centre 103 (germany) and centre 1 (netherlands), only subjects ≥ 18 years will be enrolled. * free of obvious health problems as established by medical history and clinical examination before entering into the study. * written informed consent obtained from the subject and/or from the parent or guardian of the subject. * if the subject was a female, she was of non-childbearing potential, if of childbearing potential, she was abstinent or used adequate contraceptive precautions for one month prior to enrollment and up to two months after the last vaccination exclusion criteria: * use of any investigational or non-registered drug or vaccine other than the study vaccine (s) during the study period or within 30 days preceding the first dose of study vaccine. * planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of vaccine and ending 30 days after. * previous vaccination against hepatitis b. * history of non-response to previous hepatitis b vaccination. * known exposure to hepatitis b within the past 6 weeks. * history of hepatitis b infection. * confirmed human immunodeficiency virus (hiv) infection. * a family history of congenital or hereditary immunodeficiency. * history of allergic disease or reactions likely to be exacerbated by any component of the vaccine. * acute disease at the time of enrollment. * hepatomegaly, right upper quadrant abdominal pain or tenderness. * administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration/ administration during the study period. * pregnant or lactating female

Keywords: hepatitis b adjuvanted hepatitis b vaccine recombinant hepatitis b vaccine
validating the on-line creyos cognitive assessment platform in older adults with major depressive disorder or mild cognitive impairment

Conditions: Mild Cognitive Impairment (MCI); Major Depressive Disorder, Remitted; Healthy Controls Group - Age and Sex-matched

Summary: the goal of this observational study is to validate the creyos online cognitive assessment platform in individuals with mild cognitive impairment, or remitted major depressive disorder. the main objectives of this research are: 1. to confirm the feasibility of administering the creyos cognitive battery to older adults with mild cognitive impairment mci) or major depressive disorder in remission (rmdd). 2. to determine whether the creyos battery can detect changes in cognition that are predictive of changes on paper-and-pencil neuropsychological testing ("gold standard") over up to five years. participants will complete both in-person neuropsychological testing yearly as well as the creyos online battery quarterly for up to 5 years, to allow us to compare performance on these two batteries over time.


Eligibility criteria:
general inclusion criteria: * ability to read and communicate in english * availability of a study partner who has regular contact with the participant general exclusion criteria: * lifetime dsm 5 diagnosis of schizophrenia, bipolar disorder, or ocd * dsm 5 diagnosis of alcohol or other substance use disorder within the past 12 months * high risk for suicide * significant neurological conditions (e.g. stroke, seizure disorder, ms) * unstable medical illnesses (e.g. uncontrolled diabetes mellitus or hypertension) * taking anticonvulsants or other psychotropic medication that may interfere with cognitive testing that cannot be safely tapered and discontinued * current depressive symptoms defined as a madrs score of 10 or above specific eligibility criteria for the mci group: inclusion: * aged 60 or older * meets dsm 5 criteria for minor neurocognitive disorder ("mci") exclusion: * having taken a cognitive enhancer within the past 6 weeks specific eligibility criteria for the rmdd group: inclusion: * aged 65 or older * meets dsm 5 criteria for one or more major depressive episode(s) (mde) during their adult life (i.e. 18 years of age or older) with: (a) an offset of 2 months to 5 years from the screening visit date, or (b) an offset of 5 years or more, with at least one mde receiving medical attention (e.g. previously been on an antidepressant, saw a psychiatrist, primary care physician, or had a previous hospitalization exclusion: * having taken a cognitive enhancer within the past 6 weeks * having received electroconvulsive therapy (ect) within 6 months of baseline neuropsychological testing specific eligibility criteria for the control group: inclusion: * aged 60 or older exclusion: * meets dsm 5 criteria for mdd at anytime during their lifetime * meets dsm 5 criteria for minor neurocognitive disorder ("mci")

Keywords: neuropsychological testing mild cognitive impairment online neuropsychological testing cognition
aim 3: anemia and iron management with every 3 week dosing in anemic subjects with nonmyeloid malignancies

Conditions: Cancer

Summary: the study is designed to assess if the addition of intravenous (iv) iron to 500 mcg every 3 week (q3w) darbepoetin alfa treatment enhances response as compared to the standard practice (oral iron or no iron administration).


Eligibility criteria:
inclusion criteria: - subjects with non-myeloid malignancy (chronic myeloid leukemia \[cml\], acute leukemia \[acute myelogenous leukemia (aml) and acute lymphocytic leukemia (all)\], hairy cell leukemia, burkitt's lymphoma and lymphoblastic lymphoma are specifically excluded) - planned to receive at least 8 weeks of cyclic cytotoxic chemotherapy regardless of schedule (chemotherapy may already be ongoing at time of screening) - hemoglobin concentration less than 11 g/dl within 24 hours before randomization - eastern cooperative oncology group (ecog) performance status of 0 to 2 exclusion criteria: - known (documented in medical records) history of seizure disorder (subjects with a previous history of seizure disorders will be eligible for the study, if they have had no evidence of seizure activity, and have not been taking anti-seizure medication for the previous 5 years) - known (documented in medical records) history of thromboembolism - known primary hematologic disorder which could cause anemia other than a non-myeloid malignancy (e.g., sickle cell anemia, thalassemia) - radiotherapy within 4 weeks before randomization in which the radiation is administered to greater than 25% of the marrow - unstable or uncontrolled disease/condition, related to or affecting cardiac function (e.g., unstable angina, congestive heart failure, uncontrolled hypertension and/or unstable cardiac arrhythmia) - chronic inflammatory disease that is not stable (e.g., rheumatoid arthritis, crohn's disease, peptic ulcer, ulcerative disease, etc) - inadequate renal and/or liver function - received any red blood cell transfusion within 14 days before randomization or any planned red blood cell transfusion between randomization and study day 1 - received any erythropoietic therapy within 4 weeks before randomization or any planned erythropoietic therapy between randomization and study day 1 - known sensitivity to iron administration - subject of reproductive potential is evidently pregnant (e.g., positive serum hcg test) or is breast feeding - subject of reproductive potential who is not using adequate contraceptive precautions - subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures

Keywords: oncology darbepoetin alfa aranesp® amgen non-myeloid malignancy
clinical comparison of 2 daily disposable contact lenses - pilot study 2

Conditions: Refractive Errors; Myopia

Summary: the primary objective of this study is to evaluate the overall performance of precision1 contact lenses when compared to clariti 1-day contact lenses.

subjects are expected to attend 3 study visits and wear the precision1 and clariti 1-day study lenses in a crossover design for approximately 8 days of exposure to each study lens type. the expected duration of subject participation is up to 22 days.

Eligibility criteria:
key inclusion criteria * subject must be able to understand and must sign an institution review board (irb) approved informed consent form. * successful wear of soft contact lenses in both eyes for a minimum of 5 days per week and 10 hours per day during the past 3 months. * willing to wear contact lenses for at least 16 hours per day on one of the days with each lens type. * other protocol-specified inclusion criteria may apply. key exclusion criteria: * any ocular condition that contraindicates contact lens wear. * previous or current habitual wearer of precision1, clariti 1-day, or dailies total1 contact lenses. * other protocol-specified exclusion criteria may apply.

Keywords: daily disposable contact lenses
low dose peri- operative intra venous teranexamic acid reduces blood loss after total knee arthroplasty: a double blind randomized placebo controlled clinical trial

Conditions: Knee Arthroplasty, Total

Summary: total knee arthroplasty (tka) is a common orthopedic surgery usually leads to bleeding. the null hypothesis of this study was that ta has no effect on post surgical bleeding in patients undergoes tka.


Eligibility criteria:
inclusion criteria: * individuals with osteoarthritis who indicated for primary tka. exclusion criteria: * previous history of ceberovascular diseases * previous history of myocardial infarction * candidates for bilateral tka
victus versus conventional

Conditions: Cataract

Summary: cataract surgery is among the world's most frequently performed operations. it involves removal of an opaque lens from the human eye and implantation of an artificial lens. the operation is performed under local anaesthesia using ultrasound technology, by which the lens is emulsified and removed by suction. femtosecond laser-assisted cataract surgery is a new innovative surgical procedure that can improve the quality of cataract surgery and provide a new best possible standard of quality. in contrast to the conventional method the capsulotomy and the fragemntation are fully automatically performed with a femtosecond laser. in addition, the lens is fragmented by the laser, which substantially facilitates its removal and reduces the operation time. study to investigate whether the femtosecond laser cataract surgery causes any significant differences in clinical outcomes as compared to the conventional, manual continuous curvilinear capsulorhexis (ccc). effective phako time (ept) is defined as duration of phakoemulsifikation of the crystalline lens. ept of conventional surgery at intraoperative visit \> ept oflaser-assisted surgery at intraoperative visit


Eligibility criteria:
inclusion criteria: * age 18 years * related cataract * ability to follow instructions from the treatment team * both eyes to receive surgery exclusion criteria: * narrow pupils (in ther. mydriasis \<6mm) * narrow orbits * sunken eyes * manifest glaucoma treated with anti-glaucomatous therapy or prior surgery * conditions that pose a high risk of complications during surgery * known sensitivity to planned concomitant medications * patients with disorders of the ocular muscle, such as nystagmus or strabismus * patients who are blind on one eye * acute or chronic systemic and/or ocular illnesses that are clinically significant and will increase the risk to the subject or confound the outcomes of this study, such as but not restricted to diabetes mellitus, autoimmune/rheumatic or connective tissue diseases, dementia or epilepsy. * patients who are pregnant or nursing * patients who do not give informed consent

Keywords: victus lensfragmentation femtosecond laser assisted capsulotomy, manual, continuous curvilinear capsulorhexis (ccc) effective phaco time, phaco
latinamerican vaccine effectiveness against hospitalizations due to circulating covid-19 voc rwe study

Conditions: COVID-19, SARS-CoV-2

Summary: covid-19 is the infectious disease caused by the novel coronavirus known as sars-cov-2, that appeared in 2019. the world health organisation (who) declared the novel coronavirus a pandemic on 11 march 2020. the evolution of the pandemic is varying across countries, affected in part by different containment strategies ranging from extreme lockdown to relative inaction. as a result, there are regional waves of the disease and pockets of vulnerable populations. globally, governments have acknowledged that effective vaccines against covid-19 are the only way to guarantee a safe and sustained exit strategy from repeated lockdowns. the objective of this study is to estimate the vaccine effectiveness against hospitalizations due to circulating covid-19 voc among subjects eligible for vaccination with the astrazeneca or any other covid-19 vaccine provided in their country as per national/regional immunization recommendations prior to hospital admission. the study design is an observational prospective active-surveillance hospital-based study, with a test-negative case-control design (tncc) of hospitalized covid-19 like cases undergoing testing for sars-cov-2

latinamerican vaccine effectiveness against hospitalizations due to circulating covid-19 voc rwe study is an observational prospective active-surveillance hospital-based study, with a test-negative case-control design (tncc) of hospitalized covid-19 like cases undergoing testing for sars-cov-2 by rt-pcr or rapid antigen test with the participation of countries from six latam marketing companies (argentina, brazil, colombia, costa rica, mexico and panama). this study will generate new information regarding vaccine effectiveness (ve) in the rw setting for populations where evidence is still unavailable

Eligibility criteria:
inclusion criteria: * 18y and older * ever eligible for vaccination with the astrazeneca or any other covid-19 vaccine provided in their country as per national/regional immunization recommendations prior to hospital admission. * hospitalization due to covid-19 like case * willing and able to provide informed consent (or by legal accepted representative if patient are not able to provide their signature by themselves) exclusion criteria: * cannot be swabbed or other conditions that contra-indicate swabbing * covid-19 hospitalization within 3 months prior to the current admission. hospital transfers are not considered as a prior hospitalization.
a study to assess the effect of cannabidiol oil on pain after ureteroscopy for kidney stones

Conditions: Urinary Stone

Summary: the purpose of this study is to determine if cbd oil has any effect on decreasing postoperative pain control following ureteroscopy for urinary stone disease, and to determine if cbd oil has any effect in decreasing the amount of postoperative opioids (commonly used drug) used by patients after undergoing ureteroscopy for urinary stone disease.


Eligibility criteria:
inclusion criteria: * patients who are diagnosed with kidney or ureteral stones confirmed on imaging (ct of the abdomen and pelvis) and who elect for definitive treatment via ureteroscopy at two sites within a tertiary care institution. * age 18-75 years of age. * patients of either gender. * patients of all ethnic backgrounds. * capable of giving informed consent. * capable and willing to fulfill the requirements of the study. exclusion criteria: * history of chronic pain. * chronic use of opioid or other pain medication (\> 12 weeks). * known allergy to cbd oil or other cannabinoids. * known or suspected pregnancy. * inability to give informed consent or unable to meet requirements of the study for any reason. * bilateral ureteroscopy. * current marijuana, cannabidiol (cbd), or dronabinol use. * liver disease/cirrhosis. * current treatment of seizures with clobazam, valproate, or other antiepileptic medications.
beta-tricalcium phosphate and concentrated growth factors in treatment of intra-bony defect randomized clinical trial

Conditions: Chronic Periodontitis; Intrabony Periodontal Defect; Concentrated Growth Factors

Summary: this clinical study aimed to evaluate the efficacy of biodegradable gelatin sponge loaded with beta-tricalcium phosphate socked in concentrated growth factors in the treatment of periodontal intra-bony defects, as compared with biodegradable gelatin/beta-tricalcium phosphate sponges alone.

40 intra-bony defects in 40 patients will be selected from outpatient clinic of oral periodontology clinic faculty of dentistry, tanta university to participate in this study. each defect had intra-bony depth \> or = 4 mm and probing pocket depth (ppd) \> or = 6 mm. patients will be randomly assigned to either test or control group. 20 patients will be treated by surgery plus biodegradable gelatin/beta-tricalcium phosphate sponges alone. (control group), the other 20 patients will be treated with the same surgical technique plus biodegradable gelatin sponge loaded with beta-tricalcium phosphate socked in concentrated growth factors (test group). gingival index (gi), bleeding on probing, probing pocket depth and clinical attachment level (cal) will assessed at baseline, 3, and 6 months at the site to be treated. cone beam radiographs evaluation will be taken at baseline, and 6 months after surgery.

Eligibility criteria:
inclusion criteria: * systemically healthy patients were selected * patients who had not received any medications for the previous six months that may interfere with periodontal tissue health or healing. * patients should demonstrate their ability to maintain good oral hygiene exclusion criteria: * smokers and pregnant patients. * medically compromised patients and systemic conditions precluding periodontal surgery. * subjects who do not comply with oral hygiene measures as evidenced in recall visits. * sites with tooth mobility * restoration or caries in the site to be treated or non-vital tooth * restoration or caries in the site to be treated or non-vital tooth

Keywords: beta-tricalcium phosphate regeneration concentrated growth factors